Connectomic Guided DBS for Parkinson's Disease

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT06618157
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cerebellothalamic optimized deep brain stimulation — DEVICE
    A deep brain stimulation plan will be created by maximizing the cerebellothalamic pathway on the patient-specific connectomic deep brain stimulation model
  • Pallidothalamic optimized deep brain stimulation — DEVICE
    A deep brain stimulation plan will be created by maximizing the Pallidothalamic pathway on the patient-specific connectomic deep brain stimulation model
  • No deep brain stimulation — OTHER
    Patients will also be tested without any deep brain stimulation
  • Usual care deep brain stimulation — DEVICE
    Patient will also be tested with the deep brain stimulation clinical settings that were previously established during usual care with their neurologist

Study Details

The objective of this research is to use advanced connectomic imaging models to identify disease-relevant axonal pathway targets for better tremor control in Parkinson's disease patients while avoiding undesirable side effects, with the goal of increasing precision and facilitating the choice of optimal DBS parameters for certain disease phenotypes. The investigators hypothesize that patient centered subthalamic nucleus deep brain stimulation of cerebellothalamic axonal pathways and pallidothalamic tract activation can provide better tremor control while avoiding worsening dyskinesias in patients with Parkinson's disease with significant tremor.

Key Dates

Start date
Feb 16, 2026
Status verified
Sep 2025
Primary completion
Dec 29, 2026
Completion
Jan 29, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Other: No oral dopaminergic medication
    While off of oral dopaminergic medication, MDS-UPDRS III (clinical scale) will be collected in different scenarios (each setting will be recorded for 20 minutes): during no DBS stimulation, usual care stimulation, cerebellothalamic optimized, and pallidothalamic optimized. Each participant will also wear a smartwatch (Apple watch) on each upper arm throughout the research encounter to collect total minutes with tremor, total minutes with dyskinesia, and severity of tremors and dyskinesia.
  • Other: On oral dopaminergic medication
    While on oral dopaminergic medication, MDS-UPDRS III (clinical scale) will be collected in different scenarios (each setting will be recorded for 20 minutes): during no DBS stimulation, usual care stimulation, cerebellothalamic optimized, and pallidothalamic optimized. Each participant will also wear a smartwatch (Apple watch) on each upper arm throughout the research encounter to collect total minutes with tremor, total minutes with dyskinesia, and severity of tremors and dyskinesia.

Primary Outcome Measure

Tremor duration as measured by wearables [ Time Frame: Approximately eight hours ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke Health Center at Morreene RoadDurhamNorth Carolina27705-

Find similar trials in Durham, NC

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Duke Health Center at Morreene Road· Durham, NC

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